Senior Quality Assurance Specialist

Job Description

Job Description

Senior Quality Assurance Specialist

• Location : Atlanta, GA
• Working Situation : Hybrid
• Level : Associate Level

Join a world leader in medical device innovation, transforming surgical care and improving patients' lives globally. The commitment to cutting-edge research and compassionate healthcare solutions ensures that every day brings new challenges and opportunities for growth.

Be part of a team where your expertise and passion will drive impactful advancements in medical technology.

Our client is a global medical device company who is the industry leader of new product development. Our innovative company is actively searching for a new Senior Quality Assurance Specialist our manufacturing site.

The Senior Quality Assurance Specialist would be responsible for maintaining the Sterilization Facilities QMS requirements.

The Senior Quality Assurance Specialist will be responsible for :

• Ensure timely and accurate completion of sterile load files for our products.
• Oversee the Sterile Release program for produced loads, ensuring safe and prompt product release to meet customer demands.
• Address Non-Conformances observed during sterilization processes for the facility, including opening, evaluating, and closing such cases to resolve affected loads.
• Collaborate with Sterilization Facility Personnel to investigate Non-Conformances, identifying root causes and implementing preventive measures.
• Support process improvement initiatives within the Sterilization Facility program.
• Maintain procedures pertaining to Quality Assurance - Sterilization department activities, including reviewing related procedures and records.
• Serve as a lead auditor and / or subject matter expert for quality management system audits of sterilization service providers, in compliance with relevant standards such as ISO 13485, ISO 11135, and ISO 11137.
• Develop and execute protocols for sterilization processes and equipment validation / re-validation, including generating comprehensive reports and conclusions.
• Coordinate all activities related to sterilization validations and testing, liaising with external and corporate laboratories, as well as sterilizer personnel.
• Evaluate device compatibility with various sterilization modalities, ensuring adherence to applicable ISO requirements through microbiological and sterilization theory and practice.
• Collaborate effectively within cross-functional teams, serving as both a champion and team member.
• Support business objectives and expansion plans.
• Willingness to travel domestically and internationally, up to 10% of the time.

The Senior Quality Assurance Specialist will have the following qualifications :

• Bachelor's degree in Engineering, Biology / Microbiology, Chemistry, Toxicology, or related scientific field.
• Minimum of 2 years of relevant experience.
• Experience with Sterilization Processes (Ethylene Oxide (EO), Gamma, X-Ray

If you are interested in the Senior Quality Assurance Specialist opportunity, apply now!

Company Description

DSJ Global is a revolutionary search firm, specializing in the bespoke delivery of executive search solutions to clients.

Working across a number of niche industries and sectors across the US, UK, and Europe.

With offices in New York, Charlotte, Boston, Chicago, Dallas, San Francisco, London, Zurich, Berlin, Hong Kong and Singapore, DSJ Global operates on an international scale providing bespoke search packages which are unrivaled in the widespread recruitment market.

Our aim is simple, to provide executive search level services which are flexible and tailored to the individual requirement of each client, on an unrivaled cost structure.

We currently specialize in the areas of Procurement, Supply Chain, Logistics, OPEX, Finance and Human Resources.

We believe that every client should receive the benefit and accuracy of a search approach, whilst being able to dictate how, when and where it occurs, all on a fee structure to suit.

Our revolutionary approach allows us to structure each assignment according to the requirements, time scales and budget available.

We believe that for too long executive search firms have been too rigid in their approach and have been able to dictate how the search is conducted, leaving the client relatively powerless on the outcome.

Our service allows our clients to have increased control, direction and interaction in the search conducted on their behalf and has resulted in successful, on going relationships as search firm of choice with an ever expanding client group.

Company Description

DSJ Global is a revolutionary search firm, specializing in the bespoke delivery of executive search solutions to clients.

r nWorking across a number of niche industries and sectors across the US, UK, and Europe. r nWith offices in New York, Charlotte, Boston, Chicago, Dallas, San Francisco, London, Zurich, Berlin, Hong Kong and Singapore, DSJ Global operates on an international scale providing bespoke search packages which are unrivaled in the widespread recruitment market.

Our aim is simple, to provide executive search level services which are flexible and tailored to the individual requirement of each client, on an unrivaled cost structure.

We currently specialize in the areas of Procurement, Supply Chain, Logistics, OPEX, Finance and Human Resources. r n r nWe believe that every client should receive the benefit and accuracy of a search approach, whilst being able to dictate how, when and where it occurs, all on a fee structure to suit.

Our revolutionary approach allows us to structure each assignment according to the requirements, time scales and budget available.

We believe that for too long executive search firms have been too rigid in their approach and have been able to dictate how the search is conducted, leaving the client relatively powerless on the outcome.

r n r nOur service allows our clients to have increased control, direction and interaction in the search conducted on their behalf and has resulted in successful, on going relationships as search firm of choice with an ever expanding client group.